510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882570Substantially Equivalent

Turbox Theophylline Assay

Unipath, Ltd., Bedford Mk41 Oqg, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882570 is the FDA 510(k) clearance record for TURBOX THEOPHYLLINE ASSAY, a class II device, cleared for Unipath , Ltd. on under FDA product code LER (Fluorescent Immunoassay, Theophylline). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show no recalls naming K882570.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LER Fluorescent Immunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Unipath , Ltd. Norse Rd., Bedford Mk41 Oqg, GB
Third party review
No

Clearances, product code LER

Trailing 12 months

FDA records hold no clearances under product code LER in the trailing twelve months.

FDA records show no clearances under product code LER in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LER, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260